OWN

Confocal Optical Imaging

Product code

OWN

Device name

Confocal Optical Imaging

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

13

Summaries archived here

12 (direct download)

510(k) clearances (all years, FDA)

62 (all years; only the last 3 years are listed here)

FDA classification definition

Collection of light signals for visualization of cellular microstructures.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (13)

Last three years. Most recent: 2026-07-24.

12 summaries are archived here for direct download.